Non-Invasive Blood Pressure Module
510(k) K875265
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK875265 | Date29 Feb 1988 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- DXN
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.1130
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
This device is a Non-Invasive Blood Pressure Monitor (Device Type: DXN), designed to measure arterial blood pressure without penetrating the skin. It employs photoplethysmography (PPG) technology to detect volumetric changes in peripheral blood vessels, enabling continuous or intermittent blood pressure assessment. The module is intended for clinical and research settings where non-invasive monitoring is required, such as patient care, ambulatory monitoring, or physiological studies. Its primary function is to provide systolic and diastolic blood pressure readings via signal processing algorithms.
The Non-Invasive Blood Pressure Module is supplied as a standalone component or integrated system, requiring calibration and proper setup with compatible monitoring equipment. It is classified under FDA 510(k) clearance (K875265) and was determined Substantially Equivalent to the predicate device by the Cardiovascular (CV) Advisory Committee. The module is not explicitly described as single-use or reusable in the specifications, though its design suggests potential for repeated use with appropriate maintenance. No MRI safety classification or sterility requirements are noted in the provided data.
Other devices from Ppg Industries, Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the primary purpose of the Non-Invasive Blood Pressure Module?
The module is designed to measure arterial blood pressure without penetrating the skin, using photoplethysmography (PPG) to detect volumetric changes in peripheral blood vessels. This enables continuous or intermittent blood pressure assessment, making it suitable for patient care, ambulatory monitoring, or physiological studies where non-invasive monitoring is required.
How is the Non-Invasive Blood Pressure Module supplied, and what setup is required?
The module is supplied as either a standalone component or as part of an integrated system. It requires calibration and proper setup with compatible monitoring equipment to function correctly, as it is not a self-contained device.
Is the Non-Invasive Blood Pressure Module single-use or reusable?
The specifications do not explicitly state whether the module is single-use or reusable. However, its design suggests it could be reused with appropriate maintenance, such as cleaning and calibration, depending on clinical or research protocols.
What regulatory clearance does the Non-Invasive Blood Pressure Module hold?
The module holds FDA 510(k) clearance under the reference number K875265. It was determined Substantially Equivalent to a predicate device by the Cardiovascular (CV) Advisory Committee, following a traditional review process.
Does the Non-Invasive Blood Pressure Module have any special storage or handling requirements?
The provided data does not specify any special storage or handling requirements beyond standard maintenance practices for reusable medical devices. If reused, it should be cleaned and calibrated according to manufacturer guidelines to ensure accurate and reliable performance.